03.01.00 Biologicals — Battling for biologics
Addressing access challenges for high-reward, high-cost care
By Emily Margosian
American Academy of Dermatology
For Neil Korman, MD, PhD, professor of dermatology at Case Western Reserve University and director of the Murdough Family Center for Psoriasis, few things are as frustrating as getting notice that a patient’s insurance will no longer support their biologic treatment. “I fight it but I don’t always win,” Dr. Korman said. “I often don’t win.” For prescribers of biologics, the potential promise of these drugs is often overshadowed by their high price tags. Spending on specialty treatments is expected to increase to more than 50 percent of all drug spending by 2019, and the high cost of care and subsequent limitations in access affect participants at every level of the health industry. “For myself, the patient, and my staff, it’s an enormous amount of work,” Dr. Korman said. “It’s pain and suffering for everybody.”
Burdens placed on physicians’ time and resources stand in the way of connecting patients with effective care for their conditions, and at the heart of the struggle for approval lies the uncomfortable outcome that some may be blocked from receiving any treatment at all. “The saddest situation is when they get no biologic,” said Alice Gottlieb, MD, PhD, chair, dermatologist-in-chief, and Harvey B. Ansell professor of dermatology at Tufts University School of Medicine and Tufts Medical Center. “An example I commonly see is somebody who had commercial insurance and now has Medicaid. But it’s not just Medicaid, a lot of payers are an issue. There are people with commercial payers that are very strict.”
Insurance push and pull
Many of the battles over biologics stem from the inherent nature of their composition. Unlike chemical compounds, biologics are derived from living organisms, making them more expensive to produce and tricky to substitute.
While a physician may determine why a patient should be administered one drug over another, ultimately insurers may make the final decision on what will be covered. This is troubling for the majority of prescribers. “They’ll say something other than what I’ve recommended is their preferred agent, and then I’ll say the patient already failed it,” Dr. Korman said. “I give them documentation for that, and they still deny [my recommendation].” Cost looms as the driving force behind these negotiations. “We know where that decision came from; it came from a deal that they’ve made with a company. That drug is cheaper for them so therefore it’s their preferred biologic.”
The trend toward insurers trying to drive patients to their preferred therapies can cause more than just physician frustration — switching between agents can disrupt the effectiveness of the treatments themselves. “Each biologic has different properties, even within a class,” Dr. Gottlieb said. “There are certain properties that are just different, so they are not interchangeable.”
Beyond the back and forth with insurers over preferred care, additional pushback can come in the form of lengthy paperwork that many dermatologists perceive as an effort to stall or halt prescriptions. “It’s like they’re putting roadblocks, the insurance companies, as to what they’ll cover,” said Erin Boh, MD, PhD, chair of the dermatology department at Tulane University. Dr. Gottlieb agrees. “Everything is done to try to put hurdles in the way of seeing dermatologists in the name of lowering costs,” she said. “Hurdles are put at every stage.”
Dr. Gottlieb estimated that her practice clocked in 5,280 hours of administrative time over the course of a year just to process prescriptions for biologics. “That’s for a small practice; as a chair I’m only practicing really one day a week in the clinic, and it’s still over 5,000 hours devoted to prior authorizations. When we have that many hours, other things are not getting done. Phones are not getting answered because the administrative assistant is hanging on the line with the specialty pharmacy. It’s an incredible administrative burden, for which there is no compensation, which is added to the daily tasks of our staff.”
In response to these challenges, dermatologists have adopted a variety of strategies to clear obstacles placed before them on the path to getting their prescriptions approved.
Specialty pharmacies that are willing to assist with prior authorizations can greatly reduce administrative time spent on approvals — if physicians have the right connections in place. “I started doing this about 11 or 12 years ago,” Dr. Boh said. “And I worked with my pharmacy back then. They’re willing to do it for me, but most people don’t have that luxury. If you can cultivate a relationship, that’s the way to go because they’re doing the work for me after I pick the drug. We are lucky in that regard. It’s not the best, but we get a pretty good return on our approval rate, so I’m happy with the way it works for us.” For dermatologists with the means, hiring additional staff is another option. “I have two full-time people that work with me, and I think the only people who prescribe these drugs are the ones who have the staff or resources to do it,” Dr. Korman said.
Sometimes, however, playing the game with some stealth is the path of least resistance. “When I write for a drug that needs prior authorization, first I try to find out from my major payers what the algorithm is for their prior authorization process,” Dr. Gottlieb explained. “Meaning, how many other things does a patient have to fail before they will approve a biologic? Then I try to find out more specifically what their biologics of choice are. I try to find this all out in advance, so when I’m deciding on a biologic for a patient, and know what their insurance is, I don’t ask for a certain biologic when I know they have to fail something else first. I determine those algorithms for major payers before I even suggest a particular biologic to a patient.”
Although no small amount of work, for Dr. Gottlieb this research is common sense compared to the alternative. “It is a lot of effort. But it’s also a lot of extra work to fill out all the paperwork and get the denial for a reason that I could have predicted in advance.”
Dr. Korman agrees. “A large, enormous majority of the time, I put them on methotrexate first because where I practice, this step is what they have used systematically first. So it just isn’t worth the trouble to fight through and say, oh I’m going to put you on ustekinumab or adalimumab. I’m going to put them on methotrexate first and then in three months I’ll put them on ustekinumab or adalimumab, or etanercept, or whatever. That is usually a much more effective strategy for getting the job done.”
What’s at stake for patients?
For patients with psoriasis and other chronic conditions that face reduced quality of life and social stigma due to their disease, delayed or denied biologic prescriptions can add insult to injury. “From the patient’s perspective, certainly you’ve got a frustrating disease to start with,” Dr. Boh said, “This adds layers to that frustration, especially if the patient thinks that there’s a medication out there that’s going to help them and they’re being denied. If there’s a delay, patients are uncomfortable, they feel bad, they might have a lot of psoriasis or joint pains, and you’re restricted in what you can treat them with until you can get approval of these drugs.”
An evolving understanding of how psoriasis is related to other conditions raises the stakes. “These are diseases that really affect patients dramatically in terms of their quality of life, and also have multiple comorbidities,” Dr. Korman said. “There’s evolving data that suggests if you treat aggressively with systemic agents and somebody has severe psoriasis and you can take their severe psoriasis down to mild or barely any psoriasis, then their cardiovascular disease risk, their risk for heart attack, and other cardiovascular comorbidities goes down.”
While it is easy to blame insurers when prescriptions are denied, the source of the immense cost of biologics and its effects extend further. Pharmaceutical companies have increasingly come under fire for collecting massive profits from specialty drugs used to treat chronic conditions. Most notoriously, Gilead’s hepatitis C drug, Sovaldi, has generated criticism for its set cost of $1,000 a pill.
The price of these drugs is not expected to drop anytime soon. According to Anthem, national drug spending in 2013 equaled $330 billion, whereas it is now projected that spending on specialty drugs alone could equal $400 billion by 2020. While patients typically don’t see the total costs of a drug, insurers feel their weight.
For dermatologists, while the financial burden placed on insurers explains their resistance, it is not enough to justify the struggles patients undergo to get access. “When these drugs are as expensive as they are, on some level I do understand it, but at another level it seems inappropriate to prevent patients from getting what they need because of processes in insurance plans that are frustrating and arbitrary and don’t make a lot of sense,” Dr. Korman said.
What price should be paid for specialty drugs? In a recent Morning Consult column, Len M. Nichols, PhD, suggested that prices for specialty drugs should be “high enough to keep productive R&D investment flowing into a risky and vital industry, but not whatever successful companies want to charge just because they can.” Pharmaceutical companies claim, correctly, that it is their right to charge what they want for their products within the current structuring of the American health care system. However, according to Nichols, currently the price of these drugs “far exceeds what anyone would have considered justifiable. Simply put, this level of profit is not required to induce innovation. These kinds of prices…are so unaffordable for people
and for governments that they threaten other vital health services and priorities.”
“The answer is we’re between a rock and a hard place,” Dr. Korman said. “We’re stuck in a difficult situation. If I only took care of more multimillionaires who could just write checks, it would be much easier. People who are making $40,000 a year may be barely getting by when the copay is $40. If it goes up to $80, they can’t afford it anymore.”
On the horizon
While changes in the price of biologics are unlikely to happen overnight, assistance for dermatologists and patients overwhelmed by the approval process may be on its way. Catie Coman, vice president of marketing and communications at the National Psoriasis Foundation, details the organization’s plans for a Patient Navigation Center intended to address the needs of both doctors and patients.
“Think of it as sort of an extension of a doctor’s front office and their physician extenders. We’ll be answering questions about the disease, side effects, psychosocial issues, as well as helping patients navigate the process of getting on the treatment their doctor prescribes.” The center aims to become ancillary support for dermatology offices and “fill in gaps between dermatologists and the health care industry,” by working patients through options for copay cards and other funding methods. It will also provide template letters for doctors to utilize during the appeals process. “We are essentially becoming psoriatic-disease specific social workers and case managers for these patients,” Coman said.
Scheduled to launch in January 2016, “The intention of the Patient Navigation Center is to have a one-stop shop so doctors can write their prescriptions for biologics, give patients the number for the NPF Navigation Center, and we can then help patients negotiate any appeals,” Coman said.
For all the extra hours, staff, and back-and-forth, the high stakes for the health of their patients drives dermatologists forward. “The patient is the reason why I’m doing it,” Dr. Gottlieb said. “I’m a major prescriber of biologics in the country and if it gets my patients the drugs they need, then it’s worth it.
Every clinic I get told how I changed somebody’s life, and I know I did.”
CREDIT: The previous article was included in the packet of information provided those attending the American Academy of Dermatology Association Legislative Conference.
Published in On the Road…October 2015
Battling for biologics
03.01.00 Biologicals — Battling for biologics